Noise ExposureNCT04777695
Sound Levels in the Pediatric Cardiac Critical Care Unit and Their Correlation With Sedation Administration, Delirium Scores and Patient Heart Rate
An observational study of Noise Exposure and Sedative Withdrawal Delirium, run by Children's National Research Institute at 1 site in United States.
Trial summary
There is limited data regarding sound levels and burden in the pediatric cardiac critical care unit and how this compares with WHO standards. We seek to record this data and correlate sound level with bolus sedation administration, patient delirium scores, and patient heart rate trends. Read more about this study
- Who is it for?
- Ages Up to 22 years
- Conditions the study is for
- Noise Exposure, Sedative Withdrawal Delirium, Sedative Toxicity
- What is being tested?
- Decibel Monitor
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2021to 1 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 22 years
- All sexes
- Child, Adult
Study population: Cardiac Critical Care patients include patients admitted for evaluation of congenital heart disease, status post repair of that disease, arrhythmia or for other management of pediatric patients with these conditions.
Who may be able to join
- All children admitted to the pediatric CICU during a one month period of time for patients aged 0 to less than or equal to 22 years of age, as per the World Health Organization definition of a pediatric patient.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's National Hospital
Washington D.C., District of Columbia, 20010
About this study
There is limited data regarding sound levels and burden in the pediatric cardiac critical care unit and how this compares with WHO standards. We seek to record this data and correlate sound level with bolus sedation administration, patient delirium scores, and patient heart rate trends.
Primary Outcomes
- 1 peak sound level in cardiac ICU in decibels
- 2 Mean sound level in cardiac ICU in decibels
- 3 Compare sound levels to WHO recommendations
Secondary Outcomes
- 1 To explore patient and unit factors that might influence these levels
- 2 To analyze sound levels in post-operative neonates, versus infants, versus children
- 3 To analyze patients on invasive versus non-invasine versus no ventilation
Read the detailed description
This study aims to measure and average sound levels during hospitalization in the Children's National Pediatric Cardiac Intensive Care Unit (CICU) and investigate any correlation between heightened sound levels, the incidence of delirium, the administration of sedation medications given for agitation, and patient heart rate changes. Recognition of modifiable risk factors, such as sound levels, can lead to the development of preventive strategies to keep sound levels within recommended guidelines and to lessen the amount of sedation medications that are given for agitation. Successful completion of this research will contribute to the development of modifiable environmental factors for the prevention of oversedation and delirium in critically ill children, potentially improving outcomes in a vulnerable patient population. This will be the first study of this nature performed in a large CICU and the first to look at delirium scores and vital sign changes as related to sound levels.
Many studies have shown that increased sound levels in hospitals can worsen patient agitation and lead to sleep disturbance and impair rest and healing. The World Health Organization and the Environmental Protection Agency mandate that hospital sound levels not exceed 40-45 decibels dB(A) during the day and 35 dB(A) at night. Previous studies in four European ICUs with adult patients showed that ICUs demonstrated higher than recommended sound levels 50% of the time, with an average sound level of 51 dB(A) over 24 hours and a peak sound level of 85 dB(A). In the only published study on sound levels in a pediatric CICU and their relationship to sedation administration, Guerra et al showed in 2017 that mean levels were over 59dB in both open patient areas as well as single rooms with little variation between day and night levels and that a higher peak and average sound level correlated with more sedation boluses in the subsequent 2 and 5 hours respectively.
The association between neurotoxicity and the use of sedatives and analgesia in young infants with congenital heart disease has also been described. In addition, there are appreciable negative hemodynamic effects of oversedation on the pediatric patient recovering from cardiac surgery. For this reason, it is important to investigate the impact that sound levels might have on sedation administration. Along with this, as vital sign changes such as an elevated heart rate can lead to patients receiving additional sedation, it is equally important to study the relationship between patient heart rate and sound level in a cardiac intensive care unit.
Delirium is defined as an acute and fluctuating change in attention, thinking, perception, and consciousness secondary to an underlying medical condition. The consequences of delirium have been well studied in the adult critical care population, and include prolonged hospitalization time, difficulty with long-term thinking, increased days of mechanical ventilation, and increased risk of death after discharge from the hospital. In adult intensive care units, delirium screening is routinely performed because of the known consequences of the disease. With the advent of the Cornell Assessment of Pediatric Delirium (CAPD), there is now a rapid and reliable method of screening for delirium in pediatric intensive care units. Since 2018, bedside nurses in the Children's National CICU have been trained to calculate CAP-D scores. This delirium assessment performed once per shift, can be analyzed side-by-side with average sound levels over that same shift to assess for any correlation between these two parameters.
- Being tested
- Decibel Monitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decibel MonitorOther
Placement of a TeckPro data logging sound decibel meter at all patient bed-spaces to measure concurrent sound levels 24 hours per day, over a one (1) month period. Peak and mean sound levels per hour will be collected by the decibel monitor. Sound collected every 5 minutes will be logged by the decibel monitor and downloaded onto manufacturer software daily; data will then be imported into Microsoft Excel for further data analysis.
| Study group | Role | What they receive |
|---|---|---|
| CICU Inpatients | This is a prospective observational study of all children admitted to the pediatric CICU during a one month period of time for patients aged 0 to less than or equal to 22 years of age, as per the World Health Organization definition of a pediatric patient. Receives: Other: Decibel Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure peak and mean sound levels in a cardiac ICU as well as sound dose and to compare this exposure to WHO recommendations
Measured: 1 month
Secondary outcomes (3)
To correlate sound levels and sound dose with bolus sedation administered to these patients
Measured: 1 month
To correlate sound levels and sound dose with delirium scores in these patients
Measured: 1 month
To correlate sound levels and sound dose with patient heart rate
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2021
- Study start1 Mar 2021
- Primary completion1 May 2021
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Noise ExposureStudies of the same condition, open and under way.
- More trials run by Children's National Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's National Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gregory Yurasek, MD, Principal investigator, Children's National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04777695
- Sponsor's protocol ID
- Pro00013873
- Status last verified
- Sep 2021
- First submitted
- 22 Feb 2021
- Last updated
- 1 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Garcia Guerra G, Joffe AR, Sheppard C, Pugh J, Moez EK, Dinu IA, Jou H, Hartling L, Vohra S; SedationWithdrawal and Analgesia Team (SWAT); Canadian Critical Care Trials Group (CCCTG). Prospective cohort study on noise levels in a pediatric cardiac intensive care unit. J Crit Care. 2018 Apr;44:318-322. doi: 10.1016/j.jcrc.2017.12.008. Epub 2017 Dec 14.
PubMed 29274594
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sound Levels in the Pediatric Cardiac Critical Care Unit and Their Correlation With Sedation Administration, Delirium Scores and Patient Heart Rate
- ClinicalTrials.gov ID
- NCT04777695
- Acronym / sponsor ID
- Pro00013873
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Children's National Research InstituteUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 2 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is limited data regarding sound levels and burden in the pediatric cardiac critical care unit and how this compares with WHO standards. We seek to record this data and correlate sound level with bolus sedation administration, patient delirium scores, and patient heart rate trends.
Primary Outcomes
- 1 peak sound level in cardiac ICU in decibels
- 2 Mean sound level in cardiac ICU in decibels
- 3 Compare sound levels to WHO recommendations
Secondary Outcomes
- 1 To explore patient and unit factors that might influence these levels
- 2 To analyze sound levels in post-operative neonates, versus infants, versus children
- 3 To analyze patients on invasive versus non-invasine versus no ventilation
Detailed description
This study aims to measure and average sound levels during hospitalization in the Children's National Pediatric Cardiac Intensive Care Unit (CICU) and investigate any correlation between heightened sound levels, the incidence of delirium, the administration of sedation medications given for agitation, and patient heart rate changes. Recognition of modifiable risk factors, such as sound levels, can lead to the development of preventive strategies to keep sound levels within recommended guidelines and to lessen the amount of sedation medications that are given for agitation. Successful completion of this research will contribute to the development of modifiable environmental factors for the prevention of oversedation and delirium in critically ill children, potentially improving outcomes in a vulnerable patient population. This will be the first study of this nature performed in a large CICU and the first to look at delirium scores and vital sign changes as related to sound levels.
Many studies have shown that increased sound levels in hospitals can worsen patient agitation and lead to sleep disturbance and impair rest and healing. The World Health Organization and the Environmental Protection Agency mandate that hospital sound levels not exceed 40-45 decibels dB(A) during the day and 35 dB(A) at night. Previous studies in four European ICUs with adult patients showed that ICUs demonstrated higher than recommended sound levels 50% of the time, with an average sound level of 51 dB(A) over 24 hours and a peak sound level of 85 dB(A). In the only published study on sound levels in a pediatric CICU and their relationship to sedation administration, Guerra et al showed in 2017 that mean levels were over 59dB in both open patient areas as well as single rooms with little variation between day and night levels and that a higher peak and average sound level correlated with more sedation boluses in the subsequent 2 and 5 hours respectively.
The association between neurotoxicity and the use of sedatives and analgesia in young infants with congenital heart disease has also been described. In addition, there are appreciable negative hemodynamic effects of oversedation on the pediatric patient recovering from cardiac surgery. For this reason, it is important to investigate the impact that sound levels might have on sedation administration. Along with this, as vital sign changes such as an elevated heart rate can lead to patients receiving additional sedation, it is equally important to study the relationship between patient heart rate and sound level in a cardiac intensive care unit.
Delirium is defined as an acute and fluctuating change in attention, thinking, perception, and consciousness secondary to an underlying medical condition. The consequences of delirium have been well studied in the adult critical care population, and include prolonged hospitalization time, difficulty with long-term thinking, increased days of mechanical ventilation, and increased risk of death after discharge from the hospital. In adult intensive care units, delirium screening is routinely performed because of the known consequences of the disease. With the advent of the Cornell Assessment of Pediatric Delirium (CAPD), there is now a rapid and reliable method of screening for delirium in pediatric intensive care units. Since 2018, bedside nurses in the Children's National CICU have been trained to calculate CAP-D scores. This delirium assessment performed once per shift, can be analyzed side-by-side with average sound levels over that same shift to assess for any correlation between these two parameters.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CICU Inpatients | – | Other: Decibel MonitorThis is a prospective observational study of all children admitted to the pediatric CICU during a one month period of time for patients aged 0 to less than or equal to 22 years of age, as per the World Health Organization definition of a pediatric patient. |
Who may qualify
- Ages
- Up to 22 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Cardiac Critical Care patients include patients admitted for evaluation of congenital heart disease, status post repair of that disease, arrhythmia or for other management of pediatric patients with these conditions.
Key inclusion criteria (1 listed)
- All children admitted to the pediatric CICU during a one month period of time for patients aged 0 to less than or equal to 22 years of age, as per the World Health Organization definition of a pediatric patient.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decibel MonitorPlacement of a TeckPro data logging sound decibel meter at all patient bed-spaces to measure concurrent sound levels 24 hours per day, over a one (1) month period. Peak and mean sound levels per hour will be collected by the decibel monitor. Sound collected every 5 minutes will be logged by the decibel monitor and downloaded onto manufacturer software daily; data will then be imported into Microsoft Excel for further data analysis. | Other | CICU Inpatients |
Primary outcome
To measure peak and mean sound levels in a cardiac ICU as well as sound dose and to compare this exposure to WHO recommendations
Time frame: 1 month
3 secondary outcomes
To correlate sound levels and sound dose with bolus sedation administered to these patients
Time frame: 1 month
To correlate sound levels and sound dose with delirium scores in these patients
Time frame: 1 month
To correlate sound levels and sound dose with patient heart rate
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2021.
- Results publication: PubMed 29274594Garcia Guerra G, Joffe AR, Sheppard C, Pugh J, Moez EK, Dinu IA, Jou H, Hartling L, Vohra S; SedationWithdrawal and Analgesia Team (SWAT); Canadian Critical Care Trials Group (CCCTG). Prospective cohort study on noise levels in a pediatric cardiac intensive care unit. J Crit Care. 2018 Apr;44:318-322. doi: 10.1016/j.jcrc.2017.12.008. Epub 2017 Dec 14.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory Yurasek, MD principal investigator
Children's National Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Noise Exposure and Sedative Withdrawal Delirium, run by Children's National Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To measure peak and mean sound levels in a cardiac ICU as well as sound dose and to compare this exposure to WHO recommendations (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04777695, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2021; AzTrials last refreshed its copy on 8 Nov 2026.